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Aptivus

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Aptivus

APTIVUS®
(tipranavir) Capsules

WARNING

HEPATOTOXICITY and INTRACRANIAL HEMORRHAGE

Hepatotoxicity

Clinical hepatitis and hepatic decompensation, including some fatalities, have been reported. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection, as these patients have an increased risk of hepatotoxicity [see WARNINGS AND PRECAUTIONS].

Intracranial Hemorrhage

Both fatal and non-fatal intracranial hemorrhage have been reported [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

APTIVUS is a protease inhibitor of HIV-1 belonging to the class of 4-hydroxy-5,6-dihydro-2-pyrone sulfonamides.

The chemical name of tipranavir is 2-Pyridinesulfonamide, N-[3-[(1R)-1-[(6R)-5,6-dihydro-4-hydroxy-2-oxo-6-(2-phenylethyl)-6-propyl-2H-pyran-3yl]propyl]phenyl]-5-(trifluoromethyl). It has a molecular formula of C31H33F3N2O5S and a molecular weight of 602.7. Tipranavir has the following structural formula and is a single stereoisomer with the 1R, 6R configuration.

APTIVUS® (tipranavir) Structural Formula Illustration

Tipranavir is a white to off-white to slightly yellow solid. It is freely soluble in dehydrated alcohol and propylene glycol, and insoluble in aqueous buffer at pH 7.5.

APTIVUS soft gelatin capsules are for oral administration. Each capsule contains 250 mg tipranavir. The major inactive ingredients in the capsule are dehydrated alcohol (7% w/w or 0.1 g per capsule), polyoxyl 35 castor oil, propylene glycol, mono/diglycerides of caprylic/capric acid and gelatin.

APTIVUS oral solution is available in a strength of 100 mg/mL of tipranavir. APTIVUS oral solution is a yellow, viscous clear liquid with a buttermint-butter toffee flavor. The major inactive ingredients in the oral solution are polyethylene glycol 400, vitamin E polyethylene glycol succinate (TPGS), purified water, and propylene glycol. Each milliliter of APTIVUS oral solution contains 116 IU of vitamin E, and when taken at the recommended maximum dose of 500 mg/200 mg tipranavir/ritonavir BID results in a daily dose of 1160 IU.

What are the possible side effects of tipranavir (Aptivus)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people taking tipranavir and ritonavir have developed life-threatening medical problems including liver damage and bleeding in the brain. If you are taking these two medications, call your doctor at once if you have any of the following side effects:

  • unusual bleeding (such as a nosebleed or blood in your urine or stools);
  • problems with walking, breathing, speech, swallowing, or eye...

Read All Potential Side Effects and See Pictures of Aptivus »

What are the precautions when taking tipranavir (Aptivus)?

Before taking tipranavir, tell your doctor or pharmacist if you are allergic to it; or to sulfa drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (coronary artery disease, heart attack), blood or bleeding disorders (e.g., hemophilia), other conditions causing an increased risk of bleeding (e.g., injury, surgery), high blood fat levels (cholesterol/triglyceride), other viral infections (chronic hepatitis B or hepatitis C), liver disease (including abnormal liver function tests).

This drug may make you dizzy or drowsy....

Read All Potential Precautions of Aptivus »

Last reviewed on RxList: 4/18/2014
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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